KV Backlash: Senator Condemns Pregnancy Drug Price Hike

In the wake of growing public outrage over the 150-fold increase in the price of a drug used to prevent premature birth — newly approved Makena, a form of progesterone, will cost $1,500 a dose compared with $10 for existing versions — Senator Sherrod Brown (D-Ohio) has sent a letter to manufacturer KV Pharmaceuticals asking the company to “immediately reconsider” its pricing.

“I am deeply concerned that your company appears to be taking advantage of FDA approval at the expense of women, children and federal and state budgets,” Brown wrote.

In an email, Brown said, “By ratcheting up prices, fewer women will be able to afford the drug, increasing rates of preterm birth nationwide. This isn’t in the interest of children, new mothers or taxpayers.”

Progesterone has been prescribed for other purposes for decades — but when large controlled trials showed that a long-acting form called 17-hydroxyprogesterone caproate could prevent premature birth in the mid-2000s, that compound was given “orphan drug” status by the FDA so that it could be developed for approval for this use. In the meanwhile, specialty pharmacies called “compounding pharmacies” were allowed to sell it.

Many patients have reacted with dismay and outrage to Makena’s high price. In the comments section of our earlier story, a father wrote in describing his experience with the compounded form of the drug. “Kimball” wrote:

My wife had our 1st child 7 weeks early and he spent 28 days in the NICU. The cost of this experience was just under $150,000. It was a frightening and humbling experience. Our physician prescribed hydroxyprogesterone and our second son was born at full term naturally with no complications despite my wife being dilated at 4cm for a month and 6cm for a week prior to the birth. Our third son is due Apr 30th and is now in the safe zone from major complications of premature birth. We have four shots left of this compounded drug and are SO grateful that we have already paid for the 5ml doses at $55. I’m all for capitalism but this news is actually highway robbery.

The company has not yet responded to a request for comment but has previously justified its pricing by noting the high yearly costs of premature birth and the expense of winning FDA approval for the compound.

In other bad news for KV, its former CEO, Marc Hermelin, pleaded guilty Thursday to violating drug labeling laws and was sentenced to 30 days in prison, a $1 million fine and a forfeiture of $900,000. The crime involved 30-mg and 60-mg morphine tablets that contained more of the painkiller than labeled; that may seem less egregious than selling drugs with less active ingredients than advertised, but the oversized pills could have killed patients by overdose. Hermelin was fired as KV’s CEO and chairman in 2008 but did not resign as a company director until late 2010, according to Bloomberg News.

After sentencing Hermelin, U.S. District Judge E. Richard Webber commented, “Greed, abuse of power and recklessness, that’s what I see.” Apparently, so do many others in the ongoing saga of Makena.